Influence of Vaginal Lactoferrin on Amniotic Fluid Cytokines to Avoid Pregnancy Complications

Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843984
• Other study ID #: PRUa1GR-2013-00000220-B
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: July 21, 2016
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2016
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid concentration of 47 cytokines, chemokines and growth factors.

Description:

60 women undergoing genetic amniocentesis will be enrolled at the Obstetric Unit, University of Ferrara. The selected patients will be randomly assigned to receive 300 mg of vaginal Lactoferrin to obtain 3 groups: A, 20 untreated patients; B and C (20 patients each one) respectively treated 4 and 12 h before amniocentesis. Cytokines, chemokines and growth factors concentrations will be quantified by a magnetic bead Luminex multiplex immunoassays panel technology.

Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not required for clinical purposes will be centrifuged to remove particulate material and the supernatants will be aliquoted and stored at -80°C until assay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• singleton physiological pregnancy;

• maternal age as the only indication to foetal karyotyping

Exclusion Criteria:

• assumption of drugs interfering with the immune system;

• previous miscarriages;

• pregnancy at risk for maternal or foetal disease;

• lactose intolerance.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy
• Pregnancy Complications

Intervention

Drug:
• Lactoferrin

Locations

Country	Name	City	State
Italy	Obstetric Unit, University of Ferrara	Cona	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amniotic fluid concentration of mediators involved in inflammation	The investigator will measure the amniotic fluid concentration of 47 mediators (cytokines, chemokines and growth factors) involved in the inflammatory process by Luminex multiplex immunoassays. Controls and Lactoferrin-treated patients will be compared by parametric or non-parametric statistical tests.	1 month after the enrollment of patients will be concluded.	No